Intracerebral Aneursym
Conditions
Keywords
Stent, cerebral aneursym, neurology, radiology
Brief summary
The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
Detailed description
With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.
Interventions
DEVICEMicroVention Hydrogel coil
Micro Vention Hydrogel Coils
DEVICENon-hydrogel coils
Cerecyte or bare platinum coils
Sponsors
Microvention-Terumo, Inc.
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist) 2. The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel. 3. Patients between (and including) 21 and 90 years of age. 4. Patient HUNT AND HESS Grade 0-3. 5. Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney. 6. Aneurysm 5-20mm in maximum diameter. 7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment. 8. The patient has not been previously randomized into this or another related ongoing trial. 9. The aneurysm has not previously been treated (by coiling or clipping).
Exclusion criteria
1. Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses). 2. Target aneurysm has had previous coil treatment or surgically clipped. 3. Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH). 4. Inability to obtain informed consent. 5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion rate | 12 - 18 months | Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Packing density | 12-18 months | Packing density as measured by volumetric filling of the aneurysm. |
| Clinical outcome | 6 months | Clinical outcome as measured by Modified Rankin Scale |
| Clinical Outcome | 12-18 months | Clinical outcome as measured by the Modified Rankin scale |
| Treatment related morbidity and mortality | 12-18 months | Treatment related morbidity and mortality, as measured by the NIH stroke scale; |
| Re-treatment rates | 12-18 months | Comparison of re-treatment rates at 12-18 months post treatment. |
| Cost of treatment | 12-18 months | Comparison of cost of treatment. |
| Re-bleed rates | 12-18 months | Comparison of rebleed rates at 12-18 months |
Countries
United States
Outcome results
None listed